BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM

K060277 · Boehringer Laboratories · JCX · Mar 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060277
• Device Name: BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
• Applicant: Boehringer Laboratories
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Mar 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Device Story

Powered suction pump system; provides low flow suction for fluid removal; includes rigid disposable canister accessory. Used in clinical settings for removal of irrigation fluids, body fluids, and infectious materials. Operated by healthcare professionals. Device applies suction to facilitate drainage or clearance of fluids from patient sites; assists in maintaining clean surgical or treatment fields; aids in management of infectious materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powered suction pump; low flow suction mechanism; includes rigid disposable collection canister. Similar control mechanisms and power source to predicate devices. Class II, Product Code JCX, Regulation 878.4780.

Indications for Use

Indicated for patients requiring low flow suction for the removal of irrigation fluids, body fluids, and infectious materials.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Allied Healthcare Products Gomco Thermotic Drainage Pump
• Medela Suction Pumps Median and Vario
• Pre-amendment device (K983552)

Submission Summary (Full Text)

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#### MAR 3 2006

# 2. 510(k) Summary

# 510(k) Summary

# Applicant Information:

- Name: Boehringer Laboratories Inc.
- Address: 500 E. Washington St. Norristown PA 19401
- Phone: [phone] Fax: [phone] .
- Contact: Christopher Radl, Engineering

# Trade Name:

Boehringer Laboratories Suction Pump System

### Common Name:

Powered Suction Pump

## Device Classification:

Class II Product Code: JCX Regulation 878.4780 Classification Panel: General & Plastic Surgery

### Predicate Devices:

Allied Healthcare Products Gomco Thermotic Drainage Pump Medela Suction Pumps Median and Vario

Pre-amendment device K983552

## Device Description:

The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of low flow suction. A rigid disposable canister for the collection of fluids is included as an accessory.

### Intended Use:

The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

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# Technological Characteristics:

The Boehringer Laboratories Suction Pump System is similar to the predicate Gomco Thermotic Drainage Pump and Medela Vario and Median pumps. Areas of similarity include performance parameters, control mechanisms, power source, canister for use with pumps and dimensions.

# Conclusion:

The Boehringer Laboratories Suction Pump System is substantially equivalent to the predicate Gomco Thermotic Drainage Pump and Medela Vario and Median suction pumps.

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2006 MAR 3

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boehringer Laboratories c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K060277

Trade/Device Name: Boehringer Laboratories Suction Pump System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: February 21, 2006 Received: February 23, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in merstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Job

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may Jbtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Molverson, M.S.

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K060277

# Device Name: Boehringer Laboratories Suction Pump System

Indications for Use:

The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Prescription Use × (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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Concurrence of CDF ffice of Device Evaluation (ODE)

urrence of ODRH, Office of Device LV

(Division Sign-Of Division of General, Restorative, and Neurological Devices

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